80 Participants NeededMy employer runs this trial

Vagus Nerve Stimulation for Parkinson's Disease

ER
Overseen ByElise R Carter
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how gentle electrical stimulation of the vagus nerve, applied to the ear, might improve thinking skills like decision-making in both healthy individuals and those with Parkinson's disease (PD). The process, known as transcutaneous auricular vagus nerve stimulation (taVNS), could potentially boost brain function. Participants may receive either active or sham (non-active) stimulation to assess its effects. This trial suits those with Parkinson's who don't have severe movement or thinking issues, as well as healthy individuals willing to participate. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance cognitive health.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that transcutaneous auricular vagus nerve stimulation is safe?

Research has shown that gentle electrical stimulation on the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS), is generally safe. Studies have found that while minor side effects can occur, no serious problems have been linked to this treatment. Participants in these studies, including those with Parkinson's disease, have found taVNS easy to tolerate. This suggests that taVNS is a safe option for those considering joining a clinical trial.12345

Why are researchers excited about this trial?

Most treatments for Parkinson's Disease, like levodopa and dopamine agonists, work by increasing dopamine levels in the brain. However, transcutaneous auricular vagus nerve stimulation (taVNS) offers a different approach by non-invasively stimulating the vagus nerve to potentially improve neurological function. Researchers are excited about taVNS because it provides a novel way to target brain circuits involved in Parkinson's without the need for medication, which can have significant side effects. This method could offer a new avenue for managing symptoms, especially for those who may not respond well to traditional therapies.

What evidence suggests that transcutaneous auricular vagus nerve stimulation could be effective for Parkinson's disease?

This trial will evaluate transcutaneous auricular vagus nerve stimulation (taVNS) for Parkinson's disease. Studies have shown that taVNS can improve movement problems common in Parkinson's. Research also suggests it can aid with issues like sleep and overall quality of life. Some studies report small improvements in walking speed and stride length. Overall, taVNS appears to be a promising option for enhancing certain aspects of life for those with Parkinson's disease.12346

Who Is on the Research Team?

CW

Cristin Welle, PhD

Principal Investigator

Dept. of Neurosurgery, School of Medicine, University of Colorado Anschutz Medical Campus

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65, including healthy people and those with Parkinson's disease who do not have severe movement or thinking problems. Participants must be able to give consent and follow instructions. People with serious medical issues, ear problems, electronic implants, or major vision issues cannot join.

Inclusion Criteria

I have Parkinson's disease without severe movement or thinking problems.
Ability to sign informed consent
Ability to follow written and verbal instructions
See 1 more

Exclusion Criteria

I do not have any serious or uncontrolled medical conditions right now.
I have an abnormal ear structure or a current ear infection.
Electronic medical implants, such as pacemakers, cochlear prosthesis, neuro-stimulators
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham transcutaneous auricular vagus nerve stimulation for cognitive training

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Transcutaneous Auricular Vagus Nerve Stimulation

Trial Overview

The study tests whether gentle electrical stimulation of the ear (taVNS) can improve decision-making and problem-solving in both healthy individuals and those with mild cognitive impairment or Parkinson's disease. Some participants will receive real stimulation; others will get a sham (inactive) treatment.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: active stimulation (healthy controls)Experimental Treatment1 Intervention
Group II: active stimulation (Patients with Parkinson's Disease)Experimental Treatment1 Intervention
Group III: sham stimulation (healthy controls)Placebo Group1 Intervention
Group IV: sham stimulation (patients with Parkinson's Disease)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

Citations

Effects of Transcutaneous Vagus Nerve Stimulation in ...

This study is a double-blind, randomized, controlled trial designed to evaluate the efficacy of transcutaneous auricular vagus nerve stimulation ...

Analyzing the Effectiveness of Transcutaneous Auricular ...

Our results suggest that taVNS is only partially effective in improving gait dysfunction related to Parkinson's Disease, with slight increases in walk speed ...

Home-based transcutaneous auricular vagus nerve ... - PMC

TaVNS significantly improved motor symptoms, reflected as reduced MDS-UPDRS Ⅲ scores, and alleviated non-motor symptoms including quality of ...

Home-based transcutaneous auricular vagus nerve ...

TaVNS significantly improved motor symptoms, reflected as reduced MDS-UPDRS Ⅲ scores, and alleviated non-motor symptoms including quality of life and sleep ...

Transcutaneous auricular vagus nerve stimulation in ...

taVNS was demonstrated to be safe, with no serious adverse events reported in healthy individuals or in patients with stroke or PD. In terms of ...

Transcutaneous auricular vagus nerve stimulation ...

The results supported the hypothesis that taVNS might ameliorate PD motor disorders by remolding abnormal excitability in the M1. Namely, a two- ...